Guidance for regulated products applicants

The points below will not apply to all regimes but give some general advice:

• detailed guidance is provided in the FSS guidance documents which link, where appropriate, to the relevant  EFSA guidance. Applicants should always refer to regime-specific guidance for clarification, as relevant guidance is reviewed as needed to maintain appropriate standards and support high-quality dossiers
• you should clearly explain the product’s purpose, intended use and its composition. You must provide evidence of the product’s composition and how you know the product’s authenticity. For example, it may be necessary to give the chemical name or scientific (Latin) name, depending on regime
• all the necessary technical information, as outlined in the [add link to Regulated products to regime-specific pages]regime specific guidance, should be included when you submit your application. For example, appropriate validation and/or accreditation documents for methods of analysis are required for all regimes and should be included in applications when they are submitted
• we advise following the headings and subheadings given in the relevant EFSA guidance, to aid validation. All sections must be completed by the applicant to be considered a valid dossier. If a section given in the guidance is not appropriate for the product, the dossier should include a reasoned justification as to why that is the case (e.g. history of use)
• the technical dossier should explain how the product meets the criteria set out in the relevant regulation and guidance. You should clearly list all the data provided and explain how it supports the view that the product is safe. You must submit all relevant data, whether the results are supportive of the product or not
• for most application routes, the dossier should include your analysis of the product’s risk, with enough information to verify this analysis. The focus of the analysis is that you show your understanding of the risks and identified how the risks can be managed
• where appropriate, information on the relevance and strength of the data, as well as test methods, should be included, as should an interpretation of the data. If applicable, the variability of the product should be considered when selecting the batches for testing. Applications with fewer batches than specified in the guidance must provide a full justification for the number submitted
• for dossiers that require completion of a production section, a Hazard Analysis Critical Control Plan (HACCP) is useful. The information in this section should identify whether there are new risks introduced by the production process and to what extent existing hazards from the starting material are managed. If the effectiveness of a step is supported by the product analytical testing, this should be clearly stated